MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER

Model Number	HC550JHU
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint hc550 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A distributor in (b)(4) reported that the audible alarm of a hc550 respiratory humidifier was not functioning.There was no reported patient involvement.
Additional Manufacturer Narrative
Ps375845, method: the complaint h550 respiratory humidifier was received at our fisher & paykel healthcare (f&p) regional office in us, where it was inspected by a trained f&p service technician.The device was performance tested and the audible alarm function was checked.Our investigation is based on the information provided by the f&p service technician.Results: the customer stated that the audible alarm of a hc550 respiratory humidifier was not functioning.Conclusion: we are unable to confirm the reported fault as there were no faults found during device service.The hc550 is equipped with visual alarm indicators in addition to the audible alarm.
Event or Problem Description
A distributor in ohio reported that the audible alarm of a hc550 respiratory humidifier was not functioning.There were no patient consequences.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: RESPIRATORY HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12346085
• Report Number: 9611451-2021-00934
• Device Sequence Number: 11943196
• Product Code: BTT
• UDI-Device Identifier: 09420012416810
• UDI-Public: (01)09420012416810(10)2100640050(11)181119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Device Lot Number: 2100640050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown